Study S002140

Comparison of Dapagliflozin (DAPA) and Once-weekly Exenatide (EQW), Co-administered or Alone, DAPA/ Glucophage (DAPA/MET ER) and Phentermine/Topiramate (PHEN/TPM) ER on Metabolic Profiles and Body Composition in Obese PCOS Women

ClinicalTrials.gov record Informed Consent Form (PDF)Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT02635386
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: SINGLE
Status: COMPLETED
Enrollment: 119
Start: 2016-03-22
Primary completion: 2020-07-22
Lead sponsor: Woman's
Conditions: Polycystic Ovary Syndrome; Obesity
Interventions: DRUG:Exenatide once weekly (EQW ); DRUG:Dapagliflozin (DAPA); DRUG:EQW plus DAPA; DRUG:Dapagliflozin plus Glucophage (MET ER); DRUG:Phentermine /Topiramate (PHEN/ TPM) ER
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER_GRANT:AZ ESR-14-10725

Registered primary outcomes

Oral Disposition (Insulin Sensitivity-insulin Secretion) Index [24 weeks of treatment]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0011738	Exenatide, Dapagliflozin, or Phentermine/Topiramate Differentially Affect Metabolic Profiles in Polycystic Ovary Syndrome. Elkind-Hirsch KE, The Journal of clinical endocrinology and metabolism	2021	Randomized trial	PMID 34097062 DOI	cites ClinicalTrials.gov:NCT02635386; registry reference DERIVED:34097062